← FDA ENFORCEMENT
Z-1984-2026Class II
Immuno-Mycologics, Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Immuno-Mycologics, Inc
Product type
Device
Status
Ongoing
Report date
2026-05-06
Distribution
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Firm state
OK
Product quantity
101 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Neutralization Buffer may contain contaminants
Product description
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Code / lot info
Lot: F5061154/UDI: 00816387021091
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →